A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX501 in Participants With Metastatic Non-Small Cell Lung Cancer and Advanced Solid Tumors

Study Identifier:
XTX501-01/02-001
CT.gov Identifier:
NCT07688577
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX501 as monotherapy in participants with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Non-Small Cell Lung Cancer
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Phase 1 - XTX501 Monotherapy Dose Escalation and Backfill
Read More
Drug: Part 1A will examine XTX501 monotherapy in a Bayesian Optimal Interval design to determine the maximum tolerated dose up to 10 dose regimens.
Drug: Part 1B will further evaluate the safety and antitumor activity of XTX501 at dose regimens under consideration for the recommended Phase 2 dose(s).
Drug: Drug: XTX501
Drug: XTX501 monotherapy
Drug: EXPERIMENTAL: Phase 2- XTX501 Monotherapy Dose Expansion in metastatic NSCLC
Drug: Phase 2 will further evaluate the efficacy of the selected recommended Phase 2 dose(s) in participants with metastatic NSCLC.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • * Measurable disease at baseline per RECIST v1.1
  • * ECOG performance status of 0 or 1
  • * Adequate organ function
  • * Metastatic NSCLC:
  • * Must have histologically confirmed metastatic NSCLC.
  • * Tumor must have been assessed for EGFR and ALK per local standard of practice; patients with these driver mutations are excluded.
  • * Patients with tumors known to have the following alterations are excluded: ROS1, RET, MET, HER-2, NTRK 1/2/3.
  • * Patients must have previously derived clinical benefit from a PD-1/PD-L1 inhibitor or PD-1/PDL-1 bispecific without progression for at least 6 months.
Exclusion criteria
  • Prior treatment with IL-2
  • * History of significant pulmonary disease
  • * History of clinically significant cardiovascular disease
  • * Active CNS metastases
  • * Pregnant or breastfeeding
  • In Phase 1, participants with select additional solid tumor types may be enrolled.

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

View Study Information

Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Status
Recruitment on Hold
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Solid Tumor